SPEDIFEN 400

Spedifen 400 mg is supplied as granules for an oral solution. Each sachet contains 400 mg of ibuprofen in the form of an L-arginine salt.

Ibuprofen is a non-steroidal anti-inflammatory drug – NSAID – that relieves pain, reduces inflammation and lowers fever.

The pack contains 12 sachets. The medicine is intended for adults and adolescents over 12 years and is supplied without a prescription in Serbia.

Spedifen 400 mg – uses, preparation and important precautions

Approved uses

Spedifen is used for the short-term symptomatic treatment of mild to moderate:

• headache;
• toothache;
• menstrual pain;
• neuralgia;
• bone pain;
• muscle pain.

It may also be used as supportive symptomatic treatment for fever and influenza.

Ibuprofen may mask signs of infection such as fever, pain, swelling and redness. Seek medical advice promptly if infection symptoms continue or become worse.

Dosage

Adults and adolescents over 12 years may take one 400 mg sachet two or three times daily when required.

Do not exceed three sachets or 1200 mg during 24 hours. Older patients and people with kidney, liver or heart impairment may require a lower dose.

The medicine must not be used in children under 12 years because the individual 400 mg dose is not appropriate for that age group.

Preparing the oral solution

1. Empty one sachet into 50–100 mL of still water.
2. Stir until the granules are dispersed.
3. Drink the prepared solution immediately.
4. Take it on a full stomach or with a meal.

Do not keep a prepared solution for later. Do not take a double amount after a missed dose.

Duration

• Pain: no longer than four days without medical review.
• Fever: no longer than three days without medical review.
• Adolescents aged 12–18 years: consult a doctor if treatment is required for more than three days.

When must Spedifen not be used?

• allergy to ibuprofen or another ingredient;
• a previous asthma attack, bronchospasm, rhinitis, nasal polyps, hives or angioedema caused by aspirin or another NSAID;
• active or recurrent stomach or duodenal ulcer;
• previous NSAID-related digestive bleeding or perforation;
• active gastrointestinal, cerebrovascular or other bleeding;
• ulcerative colitis or Crohn’s disease;
• severe kidney or liver impairment;
• severe heart failure;
• increased bleeding tendency;
• systemic lupus erythematosus or connective-tissue disease;
• before or immediately after heart surgery;
• phenylketonuria, because the product contains aspartame;
• the final three months of pregnancy;
• children under 12 years.

Stomach, heart and kidney risks

Ibuprofen may cause gastrointestinal ulceration, bleeding or perforation, sometimes without warning symptoms. The risk is greater in older patients, people with a previous ulcer and those using anticoagulants, antiplatelet medicines, corticosteroids or selected antidepressants.

NSAIDs may also cause fluid retention, swelling, increased blood pressure and worsening heart or kidney function. Prolonged use of higher doses may be associated with an increased risk of heart attack or stroke.

Dehydrated adolescents require particular caution because of the risk of kidney impairment.

Important interactions

Consult a doctor or pharmacist before use with:

• another NSAID or ibuprofen-containing product;
• low-dose aspirin or another antiplatelet medicine;
• warfarin, apixaban, rivaroxaban or another anticoagulant;
• corticosteroids or SSRI antidepressants;
• ACE inhibitors, angiotensin-receptor blockers, beta-blockers or diuretics;
• lithium, digoxin or phenytoin;
• methotrexate;
• ciclosporin or tacrolimus;
• selected antibiotics or antifungal medicines;
• mifepristone or baclofen.

Ibuprofen may reduce the cardiovascular antiplatelet effect of low-dose acetylsalicylic acid. Avoid alcohol because it may increase gastrointestinal and central-nervous-system adverse effects.

Pregnancy, breastfeeding and fertility

During the first six months of pregnancy, Spedifen should be used only when medically necessary, at the lowest dose for the shortest possible period.

Use after week 20 for more than several days may affect the unborn baby’s kidneys and heart and reduce amniotic fluid. The medicine is contraindicated during the final three months of pregnancy.

Use should be avoided while breastfeeding. Ibuprofen may temporarily reduce female fertility.

Possible side effects

Common effects include indigestion, diarrhoea, abdominal discomfort, nausea, wind, heartburn, headache, dizziness and skin rash.

Ulcers, digestive bleeding, vomiting, gastritis, drowsiness, hives, bronchospasm, swelling, increased blood pressure and kidney or liver impairment may also occur.

Excipients and pack

• Active ingredient: 400 mg ibuprofen per sachet as an L-arginine salt.
• Pack: 12 sachets containing 3 g of granules each.
• Aspartame: 25 mg per sachet.
• Sucrose: 1835 mg per sachet.
• Sodium: 56.98 mg per sachet.
• Appearance: white granules with a characteristic anise and peppermint odour.
• Authorisation holder: Bonifar d.o.o. Novi Beograd, Serbia.
• Manufacturer: Zambon Switzerland Ltd., Cadempino, Switzerland.
• ATC code: M01AE01.
• EAN: 8606103110046.
• Supply status in Serbia: without a prescription.

Related educational content

Serbian-language guide: Which pain medicine is the safest?

Important: dietary supplements and topical muscle-care products do not replace Spedifen for fever, headache, toothache or other acute pain.

Sources: official patient leaflet, Summary of Product Characteristics and packaging text approved by the Serbian Medicines and Medical Devices Agency – ALIMS.
Official Spedifen 400 patient leaflet | Summary of Product Characteristics
Leaflet approved: February 2025. Information checked: 3 August 2026.